Senior Quality Engineer – Medical Devices, Lead New Product

Regulatory Jobs; Alameda (CA); Presencial; USD 125.000 - 175.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Benefits package

Equity program

Paid vacation & holidays

Descripción de la vacante

Penumbra, Inc. in Alameda, CA seeks a Senior Development Quality Engineer to lead Quality Engineering for new life-saving medical devices.

You will design controls, qualify products, and ensure compliance with FDA and ISO standards across design, manufacturing, and inspection. Reporting to the Quality leadership, you will drive improvements, develop measurement methods, support FDA inspections and audits, and mentor teams in quality systems while advancing innovative therapies.

Formación

• Bachelor’s degree in Engineering or Life Science with 5+ years QA/ISO experience.
• Experience auditing, design reviews, sterilization, and project management.
• Strong communication and documentation skills.
• Medical device or regulated industry background desired.
• Advanced degree preferred.

Responsabilidades

• Lead development and qualification activities for new and existing products.
• Coordinate quality efforts across project teams to design, develop, and improve products.
• Inspect, test, and evaluate equipment; develop measurement methods.
• Ensure designs meet QMS, FDA, and ISO requirements.
• Support FDA inspections and notified body audits.
• Develop SOPs and documentation for inspection/testing.

Conocimientos

Auditing

Design review

Sterilization

Project management

Product development

Educación

Bachelor’s degree in Engineering

Advanced degree preferred

Herramientas

MS Word

Excel

PowerPoint

Descripción del empleo

Penumbra, Inc. in Alameda, CA seeks a Senior Development Quality Engineer to lead Quality Engineering for new life-saving medical devices.

You will design controls, qualify products, and ensure compliance with FDA and ISO standards across design, manufacturing, and inspection. Reporting to the Quality leadership, you will drive improvements, develop measurement methods, support FDA inspections and audits, and mentor teams in quality systems while advancing innovative therapies.